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Specific PoC Testing of Coagulation in Patients Treated With DOAC 1

NCT ID: NCT02825394

Last Updated: 2020-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-13

Study Completion Date

2021-07-31

Brief Summary

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The investigators study aims to test the correlation between the Cascade Abrazo point-of-care testing (POCT) device (Helena Laboratories, USA) and plasma levels of apixaban, dabigatran, edoxaban and rivaroxaban, and to determine the diagnostic accuracy of POCT to rule out or detect relevant levels of direct oral anticoagulants (DOAC) in real-life patients.

Detailed Description

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Conditions

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Anticoagulation With NOAC

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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apixaban initiation

N=20

anti-Xa activity point-of-care testing (aXa-POCT)

Intervention Type OTHER

apixaban on-treatment

N=20

anti-Xa activity point-of-care testing (aXa-POCT)

Intervention Type OTHER

dabigatran initiation

N=20

ecarin clotting time point-of-care testing (ECT-POCT)

Intervention Type OTHER

dabigatran on-treatment

N=20

ecarin clotting time point-of-care testing (ECT-POCT)

Intervention Type OTHER

rivaroxaban initiation

N=20

anti-Xa activity point-of-care testing (aXa-POCT)

Intervention Type OTHER

rivaroxaban on-treatment

N=20

anti-Xa activity point-of-care testing (aXa-POCT)

Intervention Type OTHER

edoxaban initiation

N=20

anti-Xa activity point-of-care testing (aXa-POCT)

Intervention Type OTHER

edoxaban on-treatment

N=20

anti-Xa activity point-of-care testing (aXa-POCT)

Intervention Type OTHER

Interventions

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anti-Xa activity point-of-care testing (aXa-POCT)

Intervention Type OTHER

ecarin clotting time point-of-care testing (ECT-POCT)

Intervention Type OTHER

Other Intervention Names

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Cascade Abrazo with ENOX and ENOX LR test cards Cascade Abrazo with DTM test cards

Eligibility Criteria

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Inclusion Criteria

* Part A only: planned initiation of treatment with apixaban, dabigatran, edoxaban or rivaroxaban
* Part B only: ongoing treatment with apixaban, dabigatran, edoxaban or rivaroxaban
* Age ≥ 18 years
* Written informed consent by patient

Exclusion Criteria

* Part A only: intake of vitamin K antagonists or direct oral anticoagulants (DOAC) ≤ 14 days prior to study participation
* Part B only: intake of vitamin K antagonists or different DOAC ≤ 14 days prior to study participation
* Intake of unfractionated heparin ≤ 12 hours, low-molecular-weight heparin ≤ 24h, heparinoids (e.g. fondaparinux) ≤ 72h, or direct thrombin inhibitors other than dabigatran ≤ 72h prior to study participation
* Part A only: abnormal routine coagulation test values at baseline (defined by INR \> 1.2, Quick \< 70% or aPTT \> 40 sec)
* History of coagulopathy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heart and Diabetes Center North Rhine-Westphalia

OTHER

Sponsor Role collaborator

University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Dr. Sven Poli

MD MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Tuebingen

Tübingen, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Sven Poli, MD MSc

Role: CONTACT

Phone: +497071290

Email: [email protected]

Florian Härtig, MD

Role: CONTACT

Phone: +497071290

Email: [email protected]

Facility Contacts

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Sven Poli, MD MSc

Role: primary

Florian Härtig, MD

Role: backup

References

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Hartig F, Birschmann I, Peter A, Horber S, Ebner M, Sonnleitner M, Spencer C, Bombach P, Stefanou MI, Tunnerhoff J, Mengel A, Kuhn J, Ziemann U, Poli S. Point-of-care testing for emergency assessment of coagulation in patients treated with direct oral anticoagulants including edoxaban. Neurol Res Pract. 2021 Mar 1;3(1):9. doi: 10.1186/s42466-021-00105-4.

Reference Type DERIVED
PMID: 33641678 (View on PubMed)

Hartig F, Birschmann I, Peter A, Ebner M, Spencer C, Gramlich M, Richter H, Kuhn J, Lehmann R, Blumenstock G, Zuern CS, Ziemann U, Poli S. Specific Point-of-Care Testing of Coagulation in Patients Treated with Dabigatran. Thromb Haemost. 2021 Jun;121(6):782-791. doi: 10.1055/s-0040-1721775. Epub 2021 Jan 14.

Reference Type DERIVED
PMID: 33469905 (View on PubMed)

Other Identifiers

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270/2015BO1

Identifier Type: -

Identifier Source: org_study_id